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Health Canada’s inability to recall unsafe drugs widely criticized

Health Canada says it is “committed to ensuring the quick recall of unsafe drugs” but cannot reveal how or when this will happen. It’s not clear if drug firms themselves would still play a lead role in the process.

The first complaint and picture of a faulty package of the generic birth control pill Alysena-28 was received by the manufacturer, Apotex, on March 20. The public was not informed abut the faulty product until April 6.
(frole.com)

Health Canada says it is “committed to ensuring the quick recall of unsafe drugs” but cannot reveal how or when this will happen.

On Saturday, a Toronto Star front page story highlighted a long-standing but little-known flaw in the Food and Drugs Act. While the federal drug regulator approves all prescription medications sold across Canada, the department confirmed it is powerless to recall these drugs when data suggest they do more harm than good.

The job of pulling problem drugs from the market falls on manufacturers and distributors. Health Canada may ask companies to stop sales or withdraw a drug. But a request is just that and may lead to a negotiation process that can take months or years before a risky product is off shelves.

Doctors, researchers, consumers and government critics have since derided the system for putting public safety in the hands of for-profit companies.

“It does seem backwards,” said Dr. Jennifer Blake, chief executive officer at the Society of Obstetricians and Gynecologists of Canada. “What’s come to light is the fact that we need to relook at the regulatory framework and bump it up a few notches.”

Whether the Conservatives’ new patient-safety legislation will provide recall power to Health Canada is unknown. Last month’s throne speech referenced plans to speed up recalls, but it’s not clear whether drug firms would still play the lead role in this process.

A spokesman in Health Minister Rona Ambrose’s office said he could not “get into details.” He said the legislation would be tabled in “due course” and would not elaborate on the timing.

Fry said the Liberals want Health Canada to have the power to order drug recalls.

“But there’s another area we have to deal with as well,” she added. The party is concerned about the length of time it takes for drug side effects to be identified once approved medications are mass circulated.

Matthew Herder, assistant professor at Dalhousie University’s Faculty of Medicine, who has participated in discussions with Health Canada about modernizing the Food and Drugs Act, shares those concerns.

“Does the manufacturer, for example, get information about adverse events and communicate it fast enough to Health Canada?” Herder asked.

A government-commissioned review of the incident found that Apotex, which began distributing the product in Canada in December 2012, first received a complaint and picture of a faulty package on March 20. The package contained an extra week’s worth of placebos and too few doses of active medication, increasing the risk of pregnancy. The placebos and active doses are different colours.

Apotex made the internal decision to recall packages on March 28. Health Canada’s regional office in Ontario didn’t get the message until April 4 and the public wasn’t informed until April 6, when media picked up reports about the recall after a drug store company posted a notice on its blog.

A class-action lawsuit against Apotex claims the faulty pills caused “40 unwanted pregnancies and four abortions,” according to the review.

Herder said he’s eager to see whether the proposed patient-safety legislation can really do enough to keep patients safe.

“To fulfill its responsibility of protecting Canadians from harm,” he said, “Health Canada should have clear legal power to order withdrawals and a legal duty to publicly explain the basis for those decisions.”

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